NCT02032238

Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: OD-OS GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab.

Detailed description

The purpose of this is study is to assess the efficacy of navigated laser treatment in reducing the number of anti-VEGF injections required to maintain visual gain obtained after Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular edema (CSME). This will be prospective, active-controlled study using Bevacizumab (Genentech, South San Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.

Conditions

• Clinically Significant Macular Edema

Interventions

Type	Name	Description
DEVICE	laser photocoagulation	Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-01-09
• Last updated: 2017-08-11
• Results posted: 2017-08-11

Locations

1 site across 1 country: United States